Novartis COPD drug Seebri Breezhaler filed in Europe

Novartis has filed Seebri Breezhaler, its once-daily treatment for chronic obstructive pulmonary disease, with regulators in Europe, having unveiled new promising data on the treatment.

The drug, which was previously-known as NVA237 (glycopyrronium bromide), is a long-acting muscarinic antagonist (LAMA), which Novartis licensed from Japan's Sosei and Vectura of the UK in April 2005. The filing has triggered a $5 million milestone payment to each of those firms.

The submission came after Novartis presented new Phase III data at the European Respiratory Society congress in Amsterdam. The GLOW1 and GLOW3 studies in COPD patients show that NVA237 significantly increased patients' lung function compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance.

David Epstein, head of Novartis Pharma, said the results illustrate the potential benefits of NVA237 for COPD patients "and are especially encouraging as we move ahead with plans to develop a fixed-dose combination with Onbrez Breezhaler (indacaterol), our once-daily therapy in the long-acting beta 2-agonist class". He said that "this investigational combination of two bronchodilators with complementary modes of action is designed to give COPD patients access to the two leading classes of therapy in a single inhaler for the first time".

Novartis flags QTI571 data at ERS

Also at ERS, Novartis announced new data from the Phase III IMPRES clinical trial showing that the investigational therapy QTI571 (imatinib) significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH) after 24 weeks compared with placebo.

“These results are impressive as they were achieved in patients who were already receiving two or more established PAH drugs,” said Marius Hoeper of the Hanover Medical School, Germany and principal investigator of the IMPRES study. An oral therapy, QTI571 works by inhibiting the activity of proliferative factors including platelet-derived growth factor, which is thought to be involved in the progression of PAH.